- We are looking for an experienced Project Manager Engineer with 7 10 years of experience in Medical Device Product Development and Lifecycle Management
- The ideal candidate will lead cross functional product development programs manage project schedules budgets resources and ensure successful delivery of innovative medical device products while maintaining compliance with quality and regulatory standards
Key Responsibilities:
- Lead end to end medical device product development projects
- Manage project scope timelines budgets risks and resources
- Coordinate with R D Design Quality Regulatory Manufacturing and Supply Chain teams
- Drive project execution from concept through design verification validation and product launch
- Monitor project deliverables and ensure adherence to project milestones
- Conduct project reviews status reporting and stakeholder communication
- Manage design control activities product changes and lifecycle management processes
- Identify and mitigate project risks and issues
- Ensure compliance with ISO 13485 ISO 14971 FDA and other applicable regulatory requirements
- Support strategic planning project governance and continuous improvement initiatives
- Mentor project teams and drive collaboration across functions
Technical Requirements:
- Medical Device Product Development
- Product Lifecycle Management PLM
- Program Project Management
- Schedule Budget Scope Management
- PMP Certified Project Management
- Current Product Development NPD
- Design Control Change Management
- Risk Management ISO 14971
- Cross functional Team Leadership
- Stakeholder Vendor Management
- Resource Planning Allocation
- Agile Waterfall Methodologies
- Product Commercialization Launch
- Regulatory Compliance FDA MDR ISO 13485
Additional Responsibilities:
- PMP Certification
- Experience in Medical Devices Healthcare Products Diagnostic Devices or Life Sciences industries
- Knowledge of PLM tools such as Windchill Teamcenter Agile PLM or similar platforms
- Experience managing global or multi site development teams
- Strong leadership communication and stakeholder management skills